Table 2

Most frequent (>5%) TEAEs and serious adverse events

Gla-300 (n = 403)Gla-100 (n = 406)
TEAEsSAEsTEAEsSAEs
n (%)n (%)n (%)n (%)
Any class237 (58.8)15 (3.7)206 (50.7)15 (3.7)
Infections and infestations133 (33.0)2 (0.5)129 (31.8)7 (1.7)
 Nasopharyngitis39 (9.7)027 (6.7)0
 Upper respiratory tract infection17 (4.2)028 (6.9)1 (0.2)
Nervous system disorders47 (11.7)1 (0.2)38 (9.4)3 (0.7)
Gastrointestinal disorders44 (10.9)1 (0.2)34 (8.4)0
Musculoskeletal and connective tissue disorders44 (10.9)041 (10.1)1 (0.2)
General disorders and administration site conditions29 (7.2)1 (0.2)29 (7.1)0
Injury, poisoning, and procedural complications34 (8.4)1 (0.2)21 (5.2)0
  • SAE, serious adverse event.

  • Other SAEs, number reported (Gla-300 and Gla-100): benign, malignant, and unspecified neoplasms, including cysts and polyps (1 and 1); metabolism and nutrition disorders (0 and 1); cardiac disorders (6 and 1); vascular disorders (0 and 1); respiratory, thoracic, and mediastinal disorders (1 and 0); skin and subcutaneous tissue disorders (1 and 1); renal and urinary disorders (0 and 1).